A senior doctor at the Norwegian drug regulatory agency suggested on Friday that the side effects of the Pfizer / BioNTech coronavirus vaccine may have contributed to the death of some older patients.
Dr. Sigurd Hortemo, chief physician of the Norwegian Medicines Agency, said in a statement that common side effects such as fever and nausea shortly after vaccination may have led to more severe results and deaths among elderly and frail patients.
According to the Norwegian Medicines Agency, as of Thursday, reports of 23 suspected deaths have been sent to the Norwegian ADR health record, including 13 reports assessed by health officials.
“We cannot rule out that adverse reactions to the vaccine that occur in the first days after vaccination (such as fever and nausea) can contribute to a more serious course and fatal outcome in patients with severe underlying disease,” the agency said in the statement.
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The statement noted that Pfizer’s large clinical trials have not tested the vaccine in patients with serious illnesses or those over 85 years of age.
In fact, prior to the emergency approval from the U.S. Food and Drug Administration, a committee that advises the agency endorsed the product and found no specific safety concerns among subgroup analyzes, but listed several unknowns that will need to be further investigated, including duration of immunity, effectiveness in certain high-risk populations, those previously infected, as well as effectiveness between asymptomatic infections, long-term effects of COVID-19 disease, mortality and transmission of SARS-CoV-2. The trial tested patients up to 85 years old.
According to Pfizer, the Norwegian agency is not alarmed by the small number of incidents.
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“Our immediate thoughts are with the bereaved families,” Pfizer wrote to Fox News in an e-mailed statement. “Pfizer and BioNTech are aware of the deaths reported after the administration of BNT162b2. We are working with the Norwegian Medicines Agency (NOMA) to gather all relevant information. Norwegian authorities have prioritized the immunization of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some who are terminally ill. “
“NOMA confirmed that the number of incidents so far is not alarming and is in line with expectations,” continues the statement. “All reported deaths will be thoroughly assessed by NOMA to determine if there is any relationship to the vaccine. The Norwegian government will also consider adjusting its vaccination instructions to take into account the health of patients.”
However, the medical director of the Norwegian drug agency advised against fragile patients receiving the vaccine.
“If you are very fragile, you probably shouldn’t be vaccinated,” Steinar Madsen, of the Norwegian Medicines Agency, told reporters on Thursday to Norway Today.
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COVID-19 vaccines typically require several weeks before the body develops sufficient immunity to protect against disease.
Injection of Pfizer has been reported to create non-serious adverse reactions such as pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, swelling at the injection site, redness at the injection site, nausea , malaise and lymphadenopathy, although experts say these symptoms usually resolve automatically several days after vaccination.
Neither the statement nor a related report specified when deaths occurred after vaccination. Fox News requested more comments from the Norwegian Medicines Agency.
Fox News’ Alexandria Hein contributed to this report.